the arthritispower wearable study

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis patients being seen at one of the participating clinical sites in a u.s. network of community rheumatology practices who are starting treatment on adalimumab or upadacitinib will be enrolled into a 24-week study combining clinical data from physicians, self-reported patient outcomes from the arthritispower registry app, and activity and sleep data from a fitbit wearable device. the primary objective of this study is: • evaluate longitudinal associations between biometric sensor data (activity and sleep measures), physician-derived data (including clinical disease activity index (cdai), rheumatoid factor (rf) lab results and other relevant biomarkers, current medications and disease duration), and patient-reported outcomes (pros) (including promis pain interference, physical function, fatigue, sleep disturbance, satisfaction with participation in discretionary social activities, and anxiety). the secondary objectives of this study are as follows: * explore the reliability and predictive validity of biometric sensor data to classify changes in ra disease activity and associated symptoms, including pros. * to assess adherence and predictors of adherence with use of biometric sensor * assess/track changes in upadacitinib and adalimumab patients using combined physician, pro and biosensor data.


Eligibility criteria:
inclusion criteria: * age 19 and above who are adults (i.e., the age of majority where they reside) * diagnosis of ra by a physician (as indicated by survey screening questions) * currently being seen by a u.s. rheumatologist * starting on the day of enrollment (with no prior use ever) or soon-to-initiate (i.e. in the next 28 days) upadacitinib or adalimumab for ra * ability to walk without the use of assistive devices; * have access to a computer or smartphone to take health assessments and a survey; * already own a smartphone (iphone or android); iphone 4s and later or android 4.3 and later * are willing to join the arthritispower patient registry; * are willing to download the arthritispower app; * are willing to contribute daily and weekly epros for at least at 89 days, and health activity tracker data for at least 84 days (lead-in period minimum of 5 days plus main study period 84 days). some participants may contribute data more than 89 days if there was a lag in receiving their medication and hence later medication start date; * are willing to wear the smartwatch while sleeping; * are willing to complete the 7-day run-in requirements (i.e. completing daily pro assessments for at least 5 of 7 days); * have started their medication within 30 days of enrolling in the study (i.e. enrolling in arthritispower) * will not be out of internet access (wifi and/or mobile data) for 4 or more consecutive days during the study; and * willing to be contacted by e-mail/text message and/or phone by the study coordinator if participants fail to adhere to the study protocol or for any study related assistance as required. * clinician must collect a cdai (including the raw scores for the four components - patient global, physician global and tender and swollen joint count) on day of enrollment. * cdai must be \>10 * must have rheumatoid and ccp antibody lab results available, or collect those labs (as part of standard of care during the enrollment visit) if not available

Keywords: patient-reported outcomes rheumatoid arthritis real world evidence wearable digital technology real world data rheumatology patients patient-generated health data mobile technology